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Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia (EXCEED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intersect ENT
ClinicalTrials.gov Identifier:
NCT02228720
First received: June 25, 2014
Last updated: April 25, 2017
Last verified: April 2017
  Purpose
This is a feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis patients undergoing sinus surgery of peripheral sinus ostia.

Condition Intervention
Chronic Sinusitis Device: Propel Nova Sinus Implant

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Propel Nova Sinus Implant
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: The EXCEED Study: A Clinical Evaluation of the Drug-Eluting Propel Nova Sinus Implant When Placed in Peripheral Sinus Ostia to Maintain Patency

Resource links provided by NLM:


Further study details as provided by Intersect ENT:

Primary Outcome Measures:
  • Device Placement Success Rate [ Time Frame: Baseline Procedure ]
    Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.


Secondary Outcome Measures:
  • Ostial Patency [ Time Frame: Baseline, Day 30, Day 90 ]
    Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)

  • Adhesion/Scarring Grade 2 & 3 [ Time Frame: Baseline, Day 30, Day 90 ]
    Adhesion/scarring grading scale from 0 (No visible granulation/scarring), 1 (Minimal amount of scarring/contraction observed but non-obstructing the frontal or maxillary sinus ostium), 2 (moderate amount of obstructive scar tissue/contraction present in the frontal or maxillary sinus ostium), 3 (Significant scar tissue/ contraction causing obstruction of the frontal or maxillary sinus ostium)

  • Degree of Inflammation [ Time Frame: Baseline, Day 30, Day 90 ]
    Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)

  • Sino-Nasal Outcome Test (SNOT) 22 [ Time Frame: Baseline, Day 30, Day 90 ]
    Validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a scale of 0 (no problem) to 5 (problem as bad as it can be), resulting in a maximum total score of 110


Enrollment: 15
Study Start Date: June 2014
Study Completion Date: January 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propel Nova Sinus Implant
Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days
Device: Propel Nova Sinus Implant
Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days
Other Name: Propel Contour Sinus Implant (mometasone furoate, 370 mcg)

Detailed Description:
This is a prospective, single-center, single-arm, open label feasibility study aiming to enroll at least 10 patients and a maximum of 15 patients to achieve 30 treated sinuses. The objective of this feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis (CS) patients undergoing sinus surgery of peripheral sinus ostia.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is ≥ 18 years of age.
  • Patient is willing and able to comply with protocol requirements.
  • Patient has CS as confirmed by CT scan and defined as symptoms lasting longer than 8 consecutive weeks in duration with inflammation of the mucosa of the nose and paranasal sinuses.
  • Patient's condition and the planned intervention will involve at least two and a maximum of four peripheral sinuses (frontal or maxillary sinuses or combination of both).
  • Patient is a candidate for a planned intervention involving sinus surgery in the operating room or office setting.
  • Patient has nasal polyps no greater than grade 2.
  • Patient with nasal polyps greater than 2 are eligible after their reduction/removal during ESS without significant complications that would confound the study results and leaving the patient's anatomy amenable to sinus implant placement, as judged by the operating physician.
  • Female patients of child-bearing potential must not be pregnant and must agree to not become pregnant during the course of the study.
  • Female patients of child-bearing potential must agree to use consistent and acceptable method/s of birth control during the course of the study.
  • CS diagnosis confirmed and documented by CT Scan within 6 months of the procedure.
  • Patient has a minimum total CT stage (Lund-Mackay method) of 6.
  • Patient has disease in frontal and/or maxillary sinuses confirmed by CT scan.
  • Planned ESS includes bilateral ethmoidectomy (if judged necessary), frontal sinus surgery using Draf II (A or B) dissection and/or balloon dilation, with minimum of 5-mm diameter opening created. In the case of maxillary sinus surgery, traditional antrostomy or balloon dilation, with or without removal of uncinate process, should be performed with minimum of 5-mm diameter opening created.
  • Technique used for frontal or maxillary sinus surgery was the same on both sides (e.g. surgical dissection alone bilaterally, balloon dilation alone bilaterally, or both bilaterally)
  • Septoplasty for access to the ostio-meatal complex is permitted.

Exclusion Criteria:

  • Patient has presence of grade 3 or 4 polyposis, unless removed during surgery and preceding implant placement.
  • Patient has presence of adhesions/scarring grades 3 or 4, unless removed during surgery and preceding implant placement.
  • Patient has known history of immune deficiency (e.g., IGG subclass deficiency or IGA deficiency, HIV).
  • Patient has concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease (e.g., cancer, HIV, etc.).
  • Patient has oral-steroid dependent condition such as COPD, asthma or other condition.
  • Patient has known history of allergy or intolerance to corticosteroids or mometasone furoate.
  • Patient has clinical evidence of acute bacterial sinusitis (e.g. acute increase in purulent discharge, fever, facial pain etc.).
  • Patient has clinical evidence or suspicion of invasive fungal sinusitis (e.g. bone erosion on prior CT scan, necrotic sinus tissue, etc.).
  • Patient has evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90-day period.
  • Patient is currently participating in another clinical trial.
  • Patient has history of insulin dependent diabetes mellitus.
  • Patient has previously undergone ESS and experienced a CSF leak or has residual compromised vision as a result of a complication in a prior ESS procedure.
  • Patient has known dehiscence of the lamina papyracea.
  • Patient has evidence of active viral illness (e.g., tuberculosis, ocular herpes simplex, chickenpox or measles).
  • Significant complication during the current peripheral ostia surgery/such as excessive blood loss, CSF leak or punctured lamina papyracea.
  • Current surgical intervention (operating room or office setting) is aborted for any reason.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02228720

Locations
United States, Florida
South Florida ENT Associates
Miami, Florida, United States, 33176
United States, Ohio
Ohio Sinus Institute
Dublin, Ohio, United States, 43016
Sponsors and Collaborators
Intersect ENT
Investigators
Principal Investigator: William J. Brown, MD South Florida ENT Associates, PA
  More Information

Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT02228720     History of Changes
Other Study ID Numbers: P500-0414
Study First Received: June 25, 2014
Results First Received: August 23, 2016
Last Updated: April 25, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Intersect ENT:
Chronic Sinusitis
Endoscopic Sinus Surgery

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 21, 2017